Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07453394
Brief Summary:
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and effectiveness of the investigational drug QLS5132 (injectable) in combination with other therapies for participants with advanced solid tumors. This is a multicenter, open-label study consisting of two parts: dose escalation and tumor-specific expansion.
The main questions it aims to answer are:
* In the dose-escalation part: What is the safety, tolerability, PK profile, and preliminary efficacy of QLS5132 combination therapy, and what are the recommended dose(s) for expansion?
* In the expansion part: What is the anti-tumor efficacy and further safety profile of QLS5132 combination therapy at the selected dose(s) in participants with specific tumor types?
Participants will:
* Be enrolled in sequential cohorts to receive QLS5132 in combination with other anticancer agents.
* Undergo regular assessments for safety, drug concentration levels (PK), and tumor response.
Study:
NCT07453394
Study Brief:
Protocol Section:
NCT07453394